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Adverse Event Manager

1 week ago

Midrand, Gauteng, South Africa Cipla Full time

Cipla is seeking a skilled Adverse Event Manager to join our team. In this role, you will assist the Drug Safety Manager in ensuring the Company's compliance with relevant laws, regulations, and guidelines governing drug safety.

You will be responsible for collecting and collating information regarding all suspected adverse reactions reported to Company employees, providing an overall view of our drug safety system.

Key Responsibilities
  • Understand various functions of PV and operational aspects.
  • Assist with day-to-day PV operational activities.
  • Act as case owner for assigned ICSRs to ensure accurate completion of data entry, data review, and regulatory reporting.
  • Ensure maintenance of a high standard of care quality processing.
  • Follow up on all AE/ADR related queries received from spontaneous/solicited reports within company timelines.
Additional Accountabilities

Support the continuous development and improvement of the PV function while upholding Cipla core values.

Conduct signal detection activities and serve as Regulatory Intelligence specialist for the PV function.